Human-challenge trials are not without risk, but they could speed up the process.
- 1Day Sooner recruited nearly 1,500 volunteers for a potential human-challenge trial to test for COVID-19 vaccines.
- Human-challenge trials could help expedite the process that clinical trials must endure.
- At least six COVID-19 vaccination trials are currently underway, with over 70 planned around the world.
Germany approves trials of COVID-19 vaccine candidate<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="fe74512eeda9131768a527f3b522fbb2"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/Cx2nIW6wAfw?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>1Day Sooner co-founder, Josh Morrison (whose organization is not funded by companies working on a coronavirus vaccine), is pre-qualifying volunteers now in case human-challenge trials are coming down the pipeline. He's hoping that this enthusiasm will help inspire politicians and public policy experts to expedite the testing process. Being a high-risk endeavor, Morrison believes the payoff could be even bigger.</p><p style="margin-left: 20px;">"Many note that they recognize the risk but believe the benefits of vaccine acceleration are so tremendous that it is worth it to them."</p><p>1Day Sooner isn't the only organization looking for a vaccine. Two volunteers <a href="https://www.bbc.com/news/health-52394485" target="_blank">were just injected</a> with COVID-19 as part of a study at Oxford—the first of over 800 people that have signed off on being tested. </p><p>Meanwhile, volunteers at Kaiser Permanente's Vaccine Treatment and Evaluation Unit in Seattle are undergoing their <a href="https://www.usatoday.com/story/news/2020/04/22/second-round-shots-first-coronavirus-vaccine-test-start/3008506001/" target="_blank">second round of vaccination trials</a>. That study began on March 16. </p><p>Hong Kong's CanSino Biologies, in partnership with the Beijing Institute of Biotechnology, has also <a href="https://fortune.com/2020/04/13/who-70-coronavirus-vaccines-human-testing/" target="_blank">just entered phase 2</a> of their clinical trials. </p><p>Clinical trials at Beth Israel are planned to launch in September, with companies such as Johnson and Johnson <a href="https://www.bostonglobe.com/2020/03/30/business/us-j-j-commit-1b-coronavirus-vaccine-co-developed-by-beth-israel/" target="_blank">dedicating $1 billion</a> to this research. </p><p>The World Health Organization announced its <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments" target="_blank">Solidarity Trial</a>, with over 100 countries participating in an effort to identify effective treatments as soon as possible. All told, the WHO announced <a href="https://fortune.com/2020/04/23/coronavirus-vaccine-update-who/" target="_blank">six coronavirus trials</a> that are currently underway, with <a href="https://fortune.com/2020/04/13/who-70-coronavirus-vaccines-human-testing/" target="_blank">over 70 planned</a> around the world. </p>
A red cross nurse applies a vaccine during a drive thru influenza vaccination operation at Riocentro on March 26, 2020 in Rio de Janeiro, Brazil. This vaccination does not prevent against the coronavirus (COVID-19), but helps the most vulnerable from other diseases.
Photo by Bruna Prado/Getty Images<p>A human-challenge trial, such as the one being proposed by 1Day Sooner, is not without potentially deadly consequences. Nir Eyal, director at the Center for Population-Level Bioethics at Rutgers University, recently said that human-challenges are not uncommon. They've been conducted on cholera and malaria. COVID-19 is a bit different, given its novelty. While we don't know the extent of damage of this virus, overall he thinks such trials are <a href="https://www.nature.com/articles/d41586-020-00927-3" target="_blank">worth the risk</a>. </p><p style="margin-left: 20px;">"The main attraction is that they could greatly accelerate the time to approval and potential use. The thing that takes the longest time in testing vaccines is phase III efficacy testing. That's done on many, many people, some of whom get the vaccine and some of whom get placebos or competing vaccine candidates. Researchers then look for differences between these two groups in infection rates."</p><p>Making a sacrifice is always a gamble, yet it points to the importance of a <a href="https://bigthink.com/politics-current-affairs/five-lessons-from-coronavirus" target="_self">collectivist mindset</a>: It's not just about you, but everyone. These volunteers deserve a lot of respect for their service.</p><p>--</p><p><span></span><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a> and <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a>. His next book is</em> "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."</p>
Two new studies shed light on the road ahead.
- Harvard researchers have recommended that intermittent social distancing measures should be in place until 2022.
- An observational study in Hong Kong found that social distancing measures have helped the nation avoid stricter lockdowns.
- America has a severe testing shortage that is delaying our ability to effectively measure the impact of COVID-19.
Researchers predict US may have to endure social distancing until 2022<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="174742300e508171dbe22873d958db8e"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/yy-yj3kFrV8?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>WHO researchers reviewed three telephone surveys between January 20 and March 13 to understand attitudinal changes as the disease progressed. They analyzed COVID-19 cases alongside influenza data and watched the reproduction number of coronavirus cases. And they discovered that a combination of behavioral changes, such as social distancing and wearing protective gear in public, border restrictions, and isolation of confirmed cases (and their contacts) helped to slow the spread.</p><p style="margin-left: 20px;">"Our findings strongly suggest that social distancing and population behavioural changes—that have a social and economic impact that is less disruptive than total lockdown—can meaningfully control COVID-19."</p><p>The researchers warn that relaxed policies, which began in March, are likely to lead to an increase in cases. Tracing is an essential strategy if nations hope to avoid serious outbreaks. Interestingly, the team noticed that social distancing also reduced influenza transmissions, which is important given that, for vulnerable populations, hospital beds are being occupied by COVID-19 patients. </p><p>Hong Kong's example could help set a precedent for other nations. The researchers write that all of these considerations need to be in place. At the moment, there does not seem to be a singular silver bullet.</p><p style="margin-left: 20px;">"Because a variety of measures were used simultaneously, we were not able to disentangle the specific effects of each one, although this may become possible in the future if some measures are strengthened or relaxed locally, or with use of cross-national or subnational comparisons of the differential application of these measures."</p><p>Meanwhile in America, officials are <a href="https://www.msnbc.com/rachel-maddow-show/texas-dan-patrick-many-seniors-willing-sacrifice-economy-n1167521" target="_blank">calling for seniors to sacrifice their lives</a> for the economy, <a href="https://www.nytimes.com/2020/04/18/health/coronavirus-america-future.html" target="_blank">testing is woefully absent</a>, and the president's sole focus is <a href="https://www.cnn.com/2020/04/18/politics/trump-economy-coronavirus/index.html" target="_blank">getting business going again</a>, health consequences be damned. These are the exact opposite measures than those health experts are proposing. </p>
Two men not observing social distancing playing basketball in Prahran with a sign outside the court reading that the court is closed on April 15, 2020 in Melbourne, Australia.
Photo by Asanka Ratnayake/Getty Images<p>A <a href="https://www.hsph.harvard.edu/news/hsph-in-the-news/intermittent-social-distancing-may-be-needed-through-2022-to-manage-covid-19/" target="_blank">new modeling study</a> from the Harvard T.H. Chan School of Public Health states that while a two or three-month distancing period flattens the curve, groups susceptible to COVID-19—<a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-higher-risk.html" target="_blank">people over 65</a> and those suffering from underlying conditions, <a href="https://www.latimes.com/science/story/2020-04-15/coronavirus-risk-higher-for-obese-people" target="_blank">as well as the obese</a>—will continue to be at risk until effective treatments and, potentially, a vaccine are produced. They're recommending that we institute social distancing policies until 2022.</p><p>Aware of a contentious response to this recommendation, they note that this isn't about politics. </p><p style="margin-left: 20px;">"The authors wrote that they're aware of the severe economic, social, and educational consequences of social distancing. They said their goal is not to advocate a particular policy but to note 'the potentially catastrophic burden on the healthcare system that is predicted if distancing is poorly effective and/or not sustained for long enough.'"</p><p>There is never a return to normal, for that supposes a societal baseline that is constant. We are moving somewhere else that will one day seem like the everyday, until it shifts again. We must take responsibility for how we transition and listen to the signal in all of this noise. For now, I only have one certainty: I'm not willing to sacrifice my parents for your portfolio.</p><p><span></span>--</p><p><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a> and <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a>. His next book is</em> "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."</p>